Integrating nutritional support into the care pathway for colorectal cancer patients Dr Sorrel Burden Lead Dietitian & Macmillan/NIHR Fellow.
Download ReportTranscript Integrating nutritional support into the care pathway for colorectal cancer patients Dr Sorrel Burden Lead Dietitian & Macmillan/NIHR Fellow.
Slide 1
Integrating nutritional support into the
care pathway for colorectal cancer
patients
Dr Sorrel Burden
Lead Dietitian &
Macmillan/NIHR Fellow
Slide 2
Research projects
Exploratory work
RCT
TNM staging/nut status
Validation of
anthropometry
Reliability of
definitions
complications
Slide 3
Nutritional status
• 86 CRC patients were recruited
• Undertook nutritional measurement
BMI
% weight loss
hand grip strength
Body composition
Slide 4
Lean body mass & fat in pts with wt loss
Percentage weight loss
<10%
Mean
(SD)
>10%
mean(SD)
Kolmogorov
-smirnov
test
Lean muscle
mass (kg)
51.9(12.1)
39.7(13.5)
0.91
0.001
5.3 to19
Fat (kg)
25.0(7.8)
22.7(10.2)
0.69
0.314
-2.3 to 7
* Independent Student t-tests , C.I confidence intervals.
P value
95% C.I
Slide 5
Nutritional & Functional Assessment
48 weight
losing
n=80
4
12
14
7
11
11
6
15
47 overweight
BMI >25
43 low
handgrip
Slide 6
Research Question for RCT
Does preoperative sip feeding decrease
postoperative complication in
colorectal cancer patients?
Slide 7
Trial Design
Pragmatic randomized control trial to
determine effectiveness
Intervention preoperative sip feeding
Control
Intervention
Dietary advice
Sip feeds (Fortisip )
& dietary advice
Slide 8
Recruitment
• Patients were recruited from colorectal
clinics over a 16M period.
• Patients were recruited at the point a
tumour was suspected.
• They were visited at home by a
Dietitian.
• Signed consent was given by all
patients.
• 3 sites
Slide 9
Trial observations
•
•
•
•
•
Sample characteristics
Anthropometry
Bioelectrical Impedance
Hand grip strength
Post operative complications
QOL Questionnaires
Slide 10
Recruitment
N u m b er o f p a tien ts
elig ib le fo r recru itm en t
n = 226
R a n d o m ise d
n= 125
P o st r a n d o m isa tio n
e x c lu sio n s
N um ber
a n a ly z e d
A llo c a te d to
a c tiv e g r o u p
A llo c a te d to
c o n tr o l g r o u p
n = 59
n = 66
n=5
n=4
n= 54
n = 62
T o ta l 1 0 1 n o t r e c r u ite d
<10 days 47
C o u ld n o t c o n ta c t 3
N o c o n se n t 3 6
T o fa r to tr a v e l 7
N o in fo r m e d c o n se n t 2
N o t a p p r o p r ia te to
c o n ta c t 6
Slide 11
Patient characteristics at baseline
A ge m ean (S D )
S ex ratio (M :F )
N um ber of sm okers
2
B M I (kg/m )
% w eight loss (m ean S D )
H andgrip (m ean S D )
T reatm ent group (S ip feeds)
n= 54
64.5 (S D 13.9)
34:20
10
25.0 S D 4.8
6.2 S D 6.8
26.3 S D
C ontrol (A dvice)
n= 62
65.3( S D 12.7)
38:24
13
26.8 S D 4.7
3.9 S D 4.8
28.2 S D
Slide 12
Site of tumour
Experimental group
no. of patients
Rectum
21
Bowel
17
Rectosigmoid 7
Anal
2
Caecal
5
Abdominal 1
Total
53
Control group
no. of patients
27
23
4
1
2
2
59
Slide 13
Length of time prior to surgery
patients had sip feeds
20
10
0
<10
21-30
11-20
41-50
31-40
No. of days enroll ed prior to s urgery
61-90
51-60
> 120
91-120
Slide 14
Energy intake pre & post op
1600
1400
1200
enrolment
1000
postop
800
600
400
200
0
Kcals
Active
Kcals
control
Slide 15
ITT- Infectious complications CDC
Treatment
Group (Sip
feeds)
Control
(Advice)
Chisquare
P value
Wound infections
9 (16)
17 (27)
2.12
0.145
Chest infections
8 (15)
14 (22)
1.54
0.125
UTI
8 (15)
6 (9)
0.125
0.724
Total No patients with
one or more infection
20 (37)
27 (43)
1.21
0.271
Slide 16
Sub group analysis ITT
(Including 71% patients 83 patients)
Treatment
n46
Control
n37
Chi-square
P value
CDC wound
5
10
3.61
0.05*
CDC chest
7
10
1.93
0.16
Buzby wound
5
10
8.4
0.03*
Buzby chest
6
8
1.9
0.37
Slide 17
Cost implications of 1 minor
complication
• cost of one minor complication £161
James (2005)
• Cost of wound infections in treatment
group £805
• Cost of same infections in the control
group is £1610
• Cost of sip feeds daily cost 10p
Slide 18
Recommendation
• Patients should be given sip feeds if
weight losing prior to surgery
• Trial specific to colorectal cancer patients
• Patients should be identified in the preop
period if weight losing.
Slide 19
Further developments
• Exploratory work to ask patients
view’s & experience of food
• Evaluate more patient centered
outcomes for nutritional support
interventions
• Look at prehabiliation
• Look at rehabilitation
• Further RCT
Slide 20
Relationship between context, problem definition,
intervention and evaluation for complex interventions
Campbell N et al. Designing and evaluating complex interventions
to improve health care. BMJ 2007;334;455-459
Integrating nutritional support into the
care pathway for colorectal cancer
patients
Dr Sorrel Burden
Lead Dietitian &
Macmillan/NIHR Fellow
Slide 2
Research projects
Exploratory work
RCT
TNM staging/nut status
Validation of
anthropometry
Reliability of
definitions
complications
Slide 3
Nutritional status
• 86 CRC patients were recruited
• Undertook nutritional measurement
BMI
% weight loss
hand grip strength
Body composition
Slide 4
Lean body mass & fat in pts with wt loss
Percentage weight loss
<10%
Mean
(SD)
>10%
mean(SD)
Kolmogorov
-smirnov
test
Lean muscle
mass (kg)
51.9(12.1)
39.7(13.5)
0.91
0.001
5.3 to19
Fat (kg)
25.0(7.8)
22.7(10.2)
0.69
0.314
-2.3 to 7
* Independent Student t-tests , C.I confidence intervals.
P value
95% C.I
Slide 5
Nutritional & Functional Assessment
48 weight
losing
n=80
4
12
14
7
11
11
6
15
47 overweight
BMI >25
43 low
handgrip
Slide 6
Research Question for RCT
Does preoperative sip feeding decrease
postoperative complication in
colorectal cancer patients?
Slide 7
Trial Design
Pragmatic randomized control trial to
determine effectiveness
Intervention preoperative sip feeding
Control
Intervention
Dietary advice
Sip feeds (Fortisip )
& dietary advice
Slide 8
Recruitment
• Patients were recruited from colorectal
clinics over a 16M period.
• Patients were recruited at the point a
tumour was suspected.
• They were visited at home by a
Dietitian.
• Signed consent was given by all
patients.
• 3 sites
Slide 9
Trial observations
•
•
•
•
•
Sample characteristics
Anthropometry
Bioelectrical Impedance
Hand grip strength
Post operative complications
QOL Questionnaires
Slide 10
Recruitment
N u m b er o f p a tien ts
elig ib le fo r recru itm en t
n = 226
R a n d o m ise d
n= 125
P o st r a n d o m isa tio n
e x c lu sio n s
N um ber
a n a ly z e d
A llo c a te d to
a c tiv e g r o u p
A llo c a te d to
c o n tr o l g r o u p
n = 59
n = 66
n=5
n=4
n= 54
n = 62
T o ta l 1 0 1 n o t r e c r u ite d
<10 days 47
C o u ld n o t c o n ta c t 3
N o c o n se n t 3 6
T o fa r to tr a v e l 7
N o in fo r m e d c o n se n t 2
N o t a p p r o p r ia te to
c o n ta c t 6
Slide 11
Patient characteristics at baseline
A ge m ean (S D )
S ex ratio (M :F )
N um ber of sm okers
2
B M I (kg/m )
% w eight loss (m ean S D )
H andgrip (m ean S D )
T reatm ent group (S ip feeds)
n= 54
64.5 (S D 13.9)
34:20
10
25.0 S D 4.8
6.2 S D 6.8
26.3 S D
C ontrol (A dvice)
n= 62
65.3( S D 12.7)
38:24
13
26.8 S D 4.7
3.9 S D 4.8
28.2 S D
Slide 12
Site of tumour
Experimental group
no. of patients
Rectum
21
Bowel
17
Rectosigmoid 7
Anal
2
Caecal
5
Abdominal 1
Total
53
Control group
no. of patients
27
23
4
1
2
2
59
Slide 13
Length of time prior to surgery
patients had sip feeds
20
10
0
<10
21-30
11-20
41-50
31-40
No. of days enroll ed prior to s urgery
61-90
51-60
> 120
91-120
Slide 14
Energy intake pre & post op
1600
1400
1200
enrolment
1000
postop
800
600
400
200
0
Kcals
Active
Kcals
control
Slide 15
ITT- Infectious complications CDC
Treatment
Group (Sip
feeds)
Control
(Advice)
Chisquare
P value
Wound infections
9 (16)
17 (27)
2.12
0.145
Chest infections
8 (15)
14 (22)
1.54
0.125
UTI
8 (15)
6 (9)
0.125
0.724
Total No patients with
one or more infection
20 (37)
27 (43)
1.21
0.271
Slide 16
Sub group analysis ITT
(Including 71% patients 83 patients)
Treatment
n46
Control
n37
Chi-square
P value
CDC wound
5
10
3.61
0.05*
CDC chest
7
10
1.93
0.16
Buzby wound
5
10
8.4
0.03*
Buzby chest
6
8
1.9
0.37
Slide 17
Cost implications of 1 minor
complication
• cost of one minor complication £161
James (2005)
• Cost of wound infections in treatment
group £805
• Cost of same infections in the control
group is £1610
• Cost of sip feeds daily cost 10p
Slide 18
Recommendation
• Patients should be given sip feeds if
weight losing prior to surgery
• Trial specific to colorectal cancer patients
• Patients should be identified in the preop
period if weight losing.
Slide 19
Further developments
• Exploratory work to ask patients
view’s & experience of food
• Evaluate more patient centered
outcomes for nutritional support
interventions
• Look at prehabiliation
• Look at rehabilitation
• Further RCT
Slide 20
Relationship between context, problem definition,
intervention and evaluation for complex interventions
Campbell N et al. Designing and evaluating complex interventions
to improve health care. BMJ 2007;334;455-459